NCT03019991

Brief Summary

The purpose of this study is to evaluate the Pharmacokinetics of Danoprevir in single dose (100mg QD on day 1, day 4 and day 14) and Ritonavir-boosted Danoprevir (100mg QD on day 4 and day 14) in single and multiple doses (100mg BID on day 5 -day 13) in healthy volunteers.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Oct 2015

Shorter than P25 for phase_1 healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 13, 2017

Completed
Last Updated

January 13, 2017

Status Verified

January 1, 2017

Enrollment Period

1 month

First QC Date

January 5, 2017

Last Update Submit

January 11, 2017

Conditions

Healthy

Keywords

pharmacokinetics,Danoprevir

Outcome Measures

Primary Outcomes (3)

  • Safety: Incidence of adverse events

    40 days

  • Pharmacokinetics: Maximum plasma concentration at steady-state (Css,max)

    Up to 16 days

  • Pharmacokinetics: Total area under the concentration-time curve form time 0 to 12 hours post-dose at steady-state

    Up to 16 days

Study Arms (2)

PK Group (Danoprevir,Ritonavir)

EXPERIMENTAL

Danoprevir(DNV)administered orally 100mg QD on day 1, day 4 and day 14;100mg BID on day 5 -day 13; Ritonavir administered orally 100mg QD on day 4 and day 14; 100mg BID on day 5 -day 13;

Drug: DanoprevirDrug: Ritonavir

Placebo Group

PLACEBO COMPARATOR

ASC 08 Placebo administered orally 100mg QD on day 1, day 4 and day 14; 100mg BID on day 5 -day 13; Ritonavir administered orally 100mg QD on day 4 and day 14; 100mg BID on day 5 -day 13 for 14 days;

Drug: RitonavirDrug: Placebo

Interventions

DanoprevirDRUG

Danoprevir(DNV)administered orally 100mg QD on day 1, day 4 and day 14; 100mg BID on day 5 -day 13

Also known as: ASC08
PK Group (Danoprevir,Ritonavir)
RitonavirDRUG

Ritonavir administered orally 100mg QD on day 4 and day 14; 100mg BID on day 5 -day 13

Also known as: RTV
PK Group (Danoprevir,Ritonavir)Placebo Group
PlaceboDRUG

ASC 08 Placebo administered orally 100mg QD on day 1, day 4 and day 14; 100mg BID on day 5 -day 13

Placebo Group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Willing and able to provide written informed consent
  • Healthy men or women based on history, physical examination, laboratory examination and ECG.
  • Negative serum or urine pregnancy test result (sensitivity of 25 mIU or better) for women with childbearing potential within the 24-hour period before the first dose of study drugs
  • Female patients with childbearing potential (menopause within 1 year) must agree to use two reliable forms of effective non-hormonal contraception (i.e., condoms, cervical barriers, intrauterine device, spermicides, or sponge), at least 1 of which must be a physical barrier method, during treatment and for at least 6 months following the last dose of ribavirin
  • All male patients with female partners of childbearing potential must use two reliable forms of effective contraception (combined) during treatment and for 6 months following the last dose of ribavirin
  • Others as specified in the detailed protocol

You may not qualify if:

  • Have medical history, or has disease, such as cardiovascular system, respiratory system, endocrine and metabolic system, urinary system, digestive system, blood system, nerve system disease or psychiatric disease and acute or chronic infectious diseases and malignant tumors.
  • Has a history of drug or food allergy.
  • Positive hepatitis A antibody，positive hepatitis B surface antigen， positive hepatitis C antibody，syphilis antibody or HIV antibody at screening.
  • Had gastrointestinal surgery, vagotomy, intestinal resection or any possible interference with gastrointestinal peristalsis, pH or absorbed by surgery.
  • Pregnant, lactating or menstrual period and unwilling to reliable contraception period women of childbearing age.
  • Female partners have fertility and reliable contraceptive measures of men.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

danoprevirRitonavir

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Huoling Tang, PhD

    Ascletis Pharmaceuticals Co., Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2017

First Posted

January 13, 2017

Study Start

October 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

January 13, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share